zenagamtide oral (NN9487 oral) / Novo Nordisk - LARVOL DELTA

A Research Study Looking at the Effect of Timing of Meal After Dosing and Water Volume at Dosing on How the Medicine Zenagamtide is Taken up by the Body of Participants With Overweight or Obesity (clinicaltrials.gov) - P1 | N=320 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P1 trial • Genetic Disorders • Obesity

Zenagamtide (amycretin), a novel unimolecular GLP-1 and amylin receptor agonist: Phase 2 results in type 2 diabetes (EASD 2026) - P2 | "Supported by: Novo Nordisk A/S Clinical Trial Registration Number: NCT06542874 Background and aims: Efficacy and safety of once-weekly s.c. and once-daily oral zenagamtide (amycretin) vs placebo in adults with type 2 diabetes (T2D) were assessed in a phase 2, 36-week, randomised, double-blind (within arm) study...Adults with T2D (HbA 1c 7.0-10.0%) on metformin ± SGLT2i were eligible... In people with T2D, once-weekly s.c. zenagamtide up to 40 mg provided clinically meaningful and statistically significant reductions in HbA 1c and body weight vs placebo, with a safety and tolerability profile consistent with other incretin and amylin-based therapies. The benefits of zenagamtide as a potential new therapeutic option for weight management and T2D will be assessed further in phase 3 trials."

P2 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of once-daily oral zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in adults with type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial. (PubMed, Lancet) - P2 | "In people with type 2 diabetes, once-daily oral zenagamtide showed clinically meaningful and significant improvements in HbA1c from baseline to week 36 compared with placebo at all three dose levels (6, 25, and 50 mg). The safety and tolerability of oral zenagamtide was consistent with other GLP-1 and amylin receptor agonists."

Journal • P2 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

AMAZE 9: A Research Study Investigating How Well Zenagamtide Tablets Help People With Excess Body Weight Lose Weight (clinicaltrials.gov) - P3 | N=950 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P3 trial • Genetic Disorders • Obesity

Zenagamtide (Amycretin), a Novel Unimolecular GLP-1 and Amylin Receptor Agonist: Phase 2b Results in T2D (ADA 2026) - "Introduction and Objective: Efficacy and safety of once-weekly (OW) s.c. and once-daily oral zenagamtide (amycretin) vs placebo (pbo) in adults with T2D were assessed in a phase 2b, 36-week, randomized, double-blind (within arm) study; OW s.c. data are reported. The OW s.c. part of the study consisted of 6 active treatment arms of increasing doses of zenagamtide (0.4-40 mg) and matched pbo. Adults with T2D (A1C 7.0-10.0%) on metformin ± SGLT2i were eligible... In people with T2D, OW s.c. zenagamtide up to 40 mg provided significant reductions in A1C and body weight vs pbo, with a safety and tolerability profile consistent with other incretin and amylin-based therapies. These results support further investigation of zenagamtide in phase 3 trials."

P2b data • Metabolic Disorders • Type 2 Diabetes Mellitus

Novo Nordisk advances cardiometabolic pipeline with new data featuring CagriSema and zenagamtide at the American Diabetes Association’s 2026 Scientific Sessions (Novo Nordisk Press Release) - "Phase 3 REIMAGINE 1–3 trial results across a range of type 2 diabetes patient groups offer further insight into CagriSema, a novel amylin RA and a GLP-1 RA in a fixed-dose combination. Mid-stage trial data for investigational zenagamtide explore the safety and efficacy of the injectable formulation of the novel GLP-1/amylin-based treatment. New Ozempic and Wegovy data provide further evidence of semaglutide's strong cardiometabolic profile."

Clinical data • Cardiovascular • Obesity • Type 2 Diabetes Mellitus

Novel Amylin-Based Therapies for Weight Management in Adults With Overweight or Obesity Without Diabetes: A Network Meta-Analysis. (PubMed, Endocrinol Diabetes Metab) - "Novel ABTs, such as HiD amycretin, CagriSema and eloralintide, may induce substantial short- to medium-term weight loss but may also increase GI AEs; given sparse, low-certainty data, these findings are preliminary and require confirmation in larger trials."

Clinical • Journal • Retrospective data • Review • Constipation • Diabetes • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Metabolic Disorders • Obesity

Zenagamtide, a Novel, Long-Acting Unimolecular GLP-1 and Amylin Receptor Agonist, Does Not Delay Gastric Emptying (ECO 2026) - P1 | "Participants initiated dose escalation with once-daily oral zenagamtide up to SS, and were subsequently switched to once-weekly s.c. zenagamtide with dose escalation up to SS... No delay in gastric emptying was observed with zenagam-tide when tested at clinically relevant oral and s.c. SS exposure levels, indicating a reduced risk of drug–drug interactions with oral drugs taken concomitantly with zenagamtide. Furthermore, no new safety findings were identified for zenagamtide. Conflicts of Interest: MBNG and SG are employees of Novo Nordisk A/S."

CNS Disorders • Diabetes • Metabolic Disorders • Movement Disorders • Parkinson's Disease • Type 2 Diabetes Mellitus

A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=448 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • CST3

Novo advances next-gen amycretin program after promising weight-loss, blood sugar data (Reuters) - "Novo's mid-stage trial, the first to test amycretin in type 2 diabetes patients, studied once-weekly subcutaneous and oral versions of the drug compared to placebo in 448 people inadequately controlled on metformin with or without an SGLT2 inhibitor, a common class of diabetes treatment...Amycretin helped patients lose up to 14.5% of their body weight over 36 weeks with weekly injections, far outperforming placebo. The oral version delivered weight loss of up to 10.1%...Amycretin showed statistically significant reductions in blood glucose levels, meeting the main goal of the study, with up to 89.1% of patients achieving HbA1c levels below 7%. Side-effects were mostly mild gastrointestinal issues, Novo said. It plans to start late-stage trials in 2026."

New trial • P2 data • Type 2 Diabetes Mellitus

Morningstar analyst Karen Andersen estimates amycretin peak sales of $8 billion in combined diabetes and obesity sales by 2034, following a 2029 launch, with roughly a 50/50 split between indications. (Reuters)

Launch US • Sales projection • Obesity • Type 2 Diabetes Mellitus

Efficacy and safety of incretin co-agonists: Transformative advances in cardiometabolic healthcare. (PubMed, World J Cardiol) - "The GLP-1 receptor agonists (GLP-1RAs), namely liraglutide, dulaglutide, albiglutide, exenatide, and semaglutide, have been found to have beneficial effects on glycated hemoglobin, weight, lipid profile, and liver fat and thereby improving cardiometabolic health. Other drugs of the same group in development include Orforglipron, which has a high weight loss efficacy (-15% weight reduction). Long-acting GLP-1RAs in trials are Ecnoglutide, Efpeglenatide, TG103, and Visepegenatide...Retatrutide and Efocipegtrutide belong to this novel group of drugs. The newer drugs in the broad category of incretin co-agonists include the GLP-1/amylin receptor agonist like CagriSema and Amycretin, oral GLP-1 agonists other than semaglutide, and the peptide YY/GLP-1 receptor dual agonists. The profound biochemical and weight loss outcomes associated with incretin co-/poly-agonists are expected to translate into outstanding cardiometabolic benefits, the theme of this evidence review."

Journal • Review • Cardiovascular • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Within R&D, Novo Nordisk will advance subcutaneous and oral amycretin into phase 3 development in weight management based on completed clinical studies during the first quarter of 2025 (Novo Nordisk Press Release) - "Further, within obesity, REDEFINE 11 has been initiated to investigate further the potential efficacy and safety of CagriSema, and semaglutide 7.2 mg (a higher dose of Wegovy) has been submitted to the EU regulatory authorities; For the 2025 outlook, sales growth is now expected to be 8-14% at CER, and operating profit growth is now expected to be 10-16% at CER...The outlook is related to lower growth expectations for Wegovy in the US obesity market, for Ozempic in the US GLP-1 diabetes market as well as for Wegovy in select IO markets."

Commercial • New P3 trial • Trial status • Diabetes • Obesity

Safety, tolerability, pharmacokinetics, and pharmacodynamics of the first-in-class GLP-1 and amylin receptor agonist, amycretin: a first-in-human, phase 1, double-blind, randomised, placebo-controlled trial. (PubMed, Lancet) - P1 | "In people with overweight or obesity, amycretin appeared safe and tolerable. Results from this first-in-human, phase 1 study support further investigation of the weight loss properties of amycretin."

Journal • P1 data • PK/PD data • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Novo Nordisk advances early-stage obesity medication, amycretin, to phase 3 clinical development based on early-phase clinical trial results in people with obesity or excess weight, published in The Lancet (Novo Nordisk Press Release) - P1 | N=144 | NCT05369390 | Sponsor: Novo Nordisk A/S | "Results from the published phase 1 trial of oral amycretin showed that the most common TEAEs were related to gastrointestinal symptoms (mainly nausea and vomiting) and decreased appetite; these were most frequent for the higher doses. Trial participants receiving the study treatment demonstrated significantly greater weight loss across the full range of doses investigated versus the placebo group.2 Exploratory results showed participants taking 100 mg per day of oral amycretin achieved a mean weight loss of 13.1% versus 1.2% with placebo after 12 weeks.....Novo Nordisk will advance...oral amycretin formulations straight to phase 3 development for weight management based on these and other completed clinical studies, as well as feedback received from regulatory authorities."

New P3 trial • P1 data • Obesity

Novo Nordisk plans to start late-stage trials of obesity drug amycretin next year (Yahoo Finance) - "Novo Nordisk said on Thursday it plans to start late-stage trials of its experimental weight-loss drug, amycretin, in injection and oral forms during the first quarter of 2026 for adults who are overweight or obese. The decision to advance the trials is based on feedback received from regulatory authorities in interactions following the end of its mid-stage trials, the company said. Amycretin, the Danish drugmaker's next-generation obesity drug, has a dual-mode action. Like its popular weight-loss drug Wegovy, amycretin not only mimics the gut hormone GLP-1, but also the effect of a hunger-suppressing pancreatic hormone called amylin."

New trial • Obesity

A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants After 10 Days of Oral Dosing (clinicaltrials.gov) - P1 | N=29 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants After 10 Days of Oral Dosing (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants After 10 Days of Oral Dosing (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P1 trial • Genetic Disorders • Obesity

Safety, tolerability and weight reduction findings of oral amycretin: a novel amylin and glucagon-like peptide-1 receptor co-agonist, in a first-in-human study (EASD 2024) - P1 | "Amidst investigations into the potential synergy beyond glucagon-like peptide-1 receptor agonists (GLP-1RAs), the combined efficacy of the amylin analogue cagrilintide and the GLP-1RA semaglutide is being explored as a subcutaneous treatment solution. Daily oral amycretin treatment in adult participants with overweight or obesity and without diabetes demonstrated acceptable safety and tolerability profiles and led to remarkable reductions in body weight over only 12 weeks. Furthermore, the lack of weight loss plateauing indicates the possibility of achieving further weight reductions with extended treatment. The results underscore the promising potential of amycretin as an anti-obesity medication and may pave the way for a novel patient-centred weight-management option."

Clinical • P1 data • Diabetes • Metabolic Disorders • Obesity

A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=432 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=432 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Novo Nordisk’s oral amycretin tops Wegovy in obesity trial (pharmaphorum) - P1 | N=144 | NCT05369390 | Sponsor: Novo Nordisk A/S | "The oral form has completed a phase 1 study, and Novo Nordisk reported results from the first 16 patients out of a total planned enrolment of 144. After 12 weeks, weight loss with the drug was 13% of body weight, compared to 1% with placebo, which the company said was around twice the level achieved with Wegovy (semaglutide) at that time point....The company's head of development, Martin Lange Holst, told the meeting that the promising results justify further research and a larger phase 2 trial is planned for the second half of this year, with results expected in around 2026."

New P2 trial • P1 data • P2 data • Metabolic Disorders • Obesity

A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity (clinicaltrials.gov) - P1 | N=144 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Novo Nordisk A/S | Active, not recruiting ➔ Completed | N=120 ➔ 36

Enrollment change • Trial completion • Genetic Disorders • Obesity